Services in the field of drug products

Our services include:
Regulatory Affairs
  • New submission of marketing authorization application (any type of applications)
  • Maintenance of marketing authorization (renewal, variations)
  • Preparation of Modules 1-5 of the registration dossier
  • Preparation of the Swiss Module 1
  • Preparation of Swiss product information and labelling
  • Creation of eCTD sequences and electronic dossiers in eDok format
  • Submission of PSUR / PBRER
  • Preparation of GSASA questionnaire for hospital products
  • Evaluation and GAP analysis of registration files
In addition: Dudler Pharma LLC has an establishment license and can be a temporary (e.g. during the registration period) or long-term Marketing Authorization Holder for your drug products.
  • Preparation of new application for admission to the list of specialties (SL) for original preparations and for generics
  • Application for new pack size and dosage
  • Application for a new clinical indication·
  • Triennial reevaluation of the admission to the SL
Quality Management
  • Application for an establishment license (import, export, wholesale, trade in foreign countries)
  • Preparation of a Site Master File
  • Preparation of inspections performed by authorities
  • Establishment and maintenance of a quality management system (QMS) which fulfills the GMP/GDP guidelines
  • Development, review and updating of Standard Operating Procedures (SOPs) and GxP agreements
  • Preparation and execution of audits (internal audits, audits of suppliers and service providers)
  • Qualification of suppliers or service providers
  • Management of transport issues
  • Management of changes
  • Management of deviations
  • Batch release for the Swiss market
  • Preparation and execution of management reviews
  • Assessment of product quality reviews (PQR) and Swiss reviews
  • Management of complaints, notification of product quality defects to Swissmedic
  • Management of recalls
  • Compliance to Falsified Medicines Directive
  • Training in quality management system
In addition: Dudler Pharma LLC has consultants who can take over the function of Responsible Person.
  • Control of the promotional material considering the legal framework
  • Evaluation of the feasibility of events for healthcare professionals
  • Set-up and maintenance of pharmacovigilance SOPs which fulfill the ICH guidelines
  • Preparation and support for authority inspections
  •  Management of Individual Case Safety reports (ICSRs)
  • Management of signals
  • Preparation of periodic safety update reports (PSUR/PBRER)
  • Preparation and updates of risk management plans (RMPs)
  • Periodic Swiss literature search 
  • Reconciliation
  • PV audits 
  • Training
In addition: Dudler Pharma LLC has consultants who can take over the function of Local Responsible Person for Pharmacovigilance.